Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer, Psychiatric, Women's Studies
Therapuetic Areas:Oncology, Psychiatry / Psychology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:August 18, 2011
End Date:July 2020

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RATIONALE: Participating in a therapy program may enhance communication and intimacy between
men with prostate cancer and their partners.

PURPOSE: This randomized clinical trial is studying how well therapy enhances communication
and intimacy for men with early stage prostate cancer and for their partners.

Aim 1 A. To evaluate the impact of an Intimacy-Enhancing Couples' intervention (IEC) versus a
General Health and Wellness Intervention (GHW) and a Usual care control (UC) on patient and
partner psychological and relationship outcomes.

B. To determine whether relationship length, pre-intervention relationship satisfaction, and
men's pre-intervention masculinity moderate the effects of IEC on couples' psychological and
relationship outcomes

Aim 2 A. To evaluate whether IEC has an effect on couples' communication and intimacy when
compared with GHW and UC and to determine whether changes in relationship communication and
intimacy mediate changes in couples' psychological and relationship outcomes.

Exploratory Aim:

A. To evaluate the impact of IEC versus GHW on physical activity and fruit and vegetable
intake as well as each partner's support for the other partner's adoption of greater physical
activity and more fruit and vegetable intake.

Inclusion Criteria:

- Patient has a primary diagnosis of localized prostate cancer (T1, T2, N=0 M=0, T3 N=0
M=0)

- Patient had surgery or initiated radiation treatment (brachytherapy or external beam
radiation) or began pre-radiation Androgen deprivation therapy within the past 12
months.

- Patient is currently married or living with a partner, with relationship duration at
least 1 year

- Patient and partner live within a 1 hour commuting distance to recruitment site

- Patient and partner read and speak English

- Patient has an Impact of Events Scale (IES) score greater than or equal to 16 and/or
partner has an IES score greater than or equal to 17.

Exclusion Criteria:

- Patient had a previous definitive treatment for prostate cancer

- Patient has a concurrent diagnosis of another cancer (other than non-melanoma skin
cancer)

- Partner is diagnosed with cancer (other than non-melanoma skin cancer)

- Patient or partner have a significant hearing impairment
We found this trial at
6
sites
New Brunswick, New Jersey 08903
Principal Investigator: Sharon L Manne, Ph.D
Phone: 732-235-9571
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Phone: 732-235-6802
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Talia I Zaider, Ph.D.
Phone: 646-888-0051
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Newark, New Jersey 07103
Principal Investigator: Mark L Jordan, MD
Phone: 732-235-6802
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Newark, NJ
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Philadelphia, Pennsylvania 19111
Principal Investigator: Carolyn Heckman, Ph.D.
Phone: 215-214-3794
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Whippany, New Jersey 07981
Principal Investigator: David Taylor, MD
Phone: 732-235-6802
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Whippany, NJ
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